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Education Program to Manage Emotional Stress of Stem Cell Transplant Recipients and Their Caregivers

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00423774
First Posted: January 18, 2007
Last Update Posted: July 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Institutes of Health Clinical Center (CC)
  Purpose

his study will evaluate a series of problem-solving education sessions for patients undergoing a stem cell transplant and their family caregivers. The emotional stress of transplant extends beyond patients to their families, especially caregivers. Little is known about managing the emotional distress associated with stem cell transplant or the support and education most helpful to caregivers of stem cell recipients.

Patients undergoing a stem cell transplant and their family caregivers may be eligible for this study. All participants must be 18 years of age and older.

Patients and their caregivers receive routine treatment-specific education from transplant team members. This study adds a series of educational sessions focusing on problem-solving skills. In addition to the study education, participants do the following:

  • Complete a 130-item questionnaire when they consent to participate in the study.
  • Complete a 60-item questionnaire and attend a 60-minute face-to-face education session before the transplant.
  • Complete a 40-item questionnaire and attend a 60-minute face-to-face education session before hospital discharge.
  • Complete the same 40-item questionnaire and attend a 60-minute face-to-face education session 2 weeks after hospital discharge.
  • Attend a 30-minute face-to-face education session 4 weeks after hospital discharge.
  • Complete a 60-item questionnaire 6 weeks after hospital discharge.

Condition Intervention Phase
Family Caregivers Bone Marrow Transplantation Behavioral: Problem-Solving Education Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Feasibility Study to Test an Individualized Dyadic Problem-Solving Education Intervention to Improve Problem-Solving Skills of Patients and Family Caregivers During Allogeneic HSCT

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Participation themes and implementation variances

Secondary Outcome Measures:
  • Problem solving skills in patient and caregiver

Enrollment: 20
Study Start Date: January 11, 2007
Study Completion Date: December 1, 2008
Primary Completion Date: December 1, 2008 (Final data collection date for primary outcome measure)
Detailed Description:

Allogeneic hematopoietic stem cell transplantation (HSCT) generates multiple symptoms and problems that can vary in complexity. Although it seems evident that patients and caregivers experience clinically significant levels of psychological distress, few intervention studies have been explored to address this concern in this population.

Problem-solving is an essential skill for patients and caregivers. Increased problem-solving skill has been shown to decrease psychological distress and may improve symptom distress and health related QOL. The COPE (Creativity, Optimism, Planning, Expert Information) problem-solving education intervention has demonstrated benefit and has been reported as a positive therapy by cancer patients and their families. Only one study has reported the application of this intervention in the acute care setting and no study has been done with patients undergoing allogeneic HSCT.

This study will evaluate the feasibility of conducting an individualized dyadic problem-solving education (PSE) intervention in patients and family caregivers experiencing allogeneic HSCT. In addition, this study will explore the effect of a PSE intervention on problem-solving skills in patients and family caregivers experiencing allogeneic HSCT. Moreover, this study will explore the relationship of baseline psychological distress and family functioning to change in problem-solving skills following a PSE intervention.

This is a single group, mixed-methods, repeated measure design. Subjects will be accrued to this protocol if they agree to participation in an allogeneic HSCT at the Clinical Center, NIH, are greater than or equal to 18 years old, able to read English and able to comprehend the investigational nature of the study. Patient volunteers must have an adult family member to serve as their primary caregiver throughout the study period. A sample of 20 subjects (10 patient/family caregiver dyads) will be recruited to capture the essence of the experience and adequately evaluate the feasibility of the intervention in this sample.

Each dyad will be scheduled for four individualized PSE intervention sessions (study intervention) in addition to the usual care group education. Study questionnaires will be administered twice prior to allogeneic HSCT, at 2 time points during the intervention period, and at the end of the study. As a feasibility study, there will be no long term follow-up after the intervention period. Questionnaires include: Brief Symptom Inventory-18, Problem-Solving Inventory-Revised, Symptom Distress Scale, and the Family Adaptability-Cohesion Evaluation Scale-IV. In addition, the dyad will participate in a semi-structured interview at the end of each intervention session and the interventionist will complete a log that tracks subject attendance, session length, and discrepancy between planned and actual session date and time. Quantitative and qualitative analysis techniques will be used in this study.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

Patients: Receiving their first allogeneic HSCT at the CC, NIH

Age greater than or equal to 18 years old.

Ability to comprehend the investigational nature of the study and provide informed consent.

Able to read and speak English.

Adult family member serves as primary caregiver throughout study period.*

Family caregiver agrees to participate in the study.

Family Caregiver (FC):

Age greater than or equal to 18 years old.

Ability to comprehend the investigational nature of the study and provide informed consent.

Able to read and speak English.

Adult family member who meets the patient inclusion criteria.

Family member (patient) agrees to participate in the study.

Intends to serve as primary caregiver throughout study period*

*If the FC changes during the study, the PSE intervention will continue as scheduled with the new FC, however, FC data will no longer be collected and will be excluded from the analyses.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00423774


Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Institutes of Health Clinical Center (CC)
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00423774     History of Changes
Other Study ID Numbers: 070067
07-CC-0067
First Submitted: January 17, 2007
First Posted: January 18, 2007
Last Update Posted: July 2, 2017
Last Verified: September 28, 2010

Keywords provided by National Institutes of Health Clinical Center (CC):
Allogeneic Hematopoietic Stem Cell Transplant
Psychological Distress
Coping
Cognitive Behavior Therapy
Bone Marrow Transplant
Coping Skills